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SonarMed AirWave

FDA UDI

Class II (US FDA UDI)

by Sonarmed, Inc.

Identity

Trade Name
SonarMed AirWave FDA UDI
Generic Name
Endotracheal secretion monitoring system FDA UDI
Device Name
AirWave Sensor - Neonatal Medium - for use with endotracheal tubes of 3.0 mm ID FDA UDI
Model / Reference
AW-S0005 FDA UDI
Description
AirWave Sensor - Neonatal Medium - for use with endotracheal tubes of 3.0 mm ID FDA UDI

Identifiers

Primary DI / UDI-DI
00851334007056 FDA UDI
510(k) Number
K143042 FDA UDI
FDA Product Code
OQU FDA UDI
GMDN Term
Endotracheal secretion monitoring system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.5730 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Endotracheal secretion monitoring system

SonarMed AirWave by Sonarmed, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Endotracheal secretion monitoring system.

Cleared under the same submission

K143042 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Sonarmed, Inc.

Sources (1)

  • FDA UDI 84159fe8-dee4-4461-8ca4-2589957ac0bb 34 fields · synced May 30, 2026